HERmark provides a precise and quantitative measurement of HER2 total protein and HER2 homodimer levels. Physicians currently use semi-quantitative measures to determine HER2 status as an indicator of HER2 protein over-expression or HER2 gene amplification to determine whether or not to prescribe Herceptin(R). Inaccurate measurements of HER2 status may lead to inappropriate therapy selection. Guidance recently issued jointly by ASCO (American Society of Clinical Oncology) and CAP (the College of American Pathologists) indicated that approximately 20% of HER2 determinations by current testing technologies may be inaccurate.
"We have correlated the HERmark assay with IHC, FISH and CISH results obtained in central laboratories in more than one thousand patients, and we see a high degree of concordance between the best central lab tests and HERmark," said Michael Bates, M.D., Vice President of Clinical Research at Monogram. "Importantly, HERmark identifies patients with high HER2 levels but who are HER2-negative by other assays, as well as some patients with low HER2 levels but who are judged positive by conventional assays. Comparisons with local lab results by IHC or FISH suggest significantly larger numbers of discordant results. We believe the HERmark Assay measures HER2 total protein and homodimer levels very accurately and will help physicians to make treatment decisions with high confidence."
Monogram has ongoing and planned clinical studies to assess HERmark as
a predictor of Herceptin response in both the metastatic and adjuvant
settings. Preliminary results of one such study in metastatic breast cancer
were presented by collaborators earlier this year at ASCO ("Total HER2 and
HER2 Homodimer Levels Predict Response to trastuzumab.") Additional
clinical analyses of this cohort will be presented at the San
|SOURCE Monogram Biosciences, Inc.|
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